From the PDR Network:
For all the good that extended-release and long-acting opioid analgesics do—which is considerable when they are used appropriately in the right patients—their misuse and abuse have us facing a significant public health crisis. We’ve all seen the statistics, and heard everyone from members of Congress to medical and mainstream media refer to an “epidemic” of prescription drug overdoses, with ER/LA opioids perceived to be the primary vehicle.
This presents a dilemma: How do we as a society maintain access to these important medications for the patients who desperately need them while keeping these potentially dangerous substances out of the hands of those at risk (eg, addicts, drug seekers, innocent children, under-informed patients), all without imposing onerous restrictions on healthcare professionals who are trying to provide their patients with compassionate care?
The FDA took a significant step in addressing this issue when it approved a Risk Evaluation and Mitigations Strategy (REMS) for ER/LA opioid analgesics. It’s the largest REMS program to date, covering 35 branded and generic drugs made by more than 20 manufacturers. These competitors are now working together to provide and promote essential safety education that includes prescriber training, a patient counseling document, and Medication Guides that will be unique to each ER/LA opioid analgesic product.
The first REMS-compliant training is expected to be available from accredited continuing education providers in March of 2013, funded by the ER/LA opioid analgesics REMS companies
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